BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3161555 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14913
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED AND AN EVALUATION WAS PERFORMED ON THE DEVICE. VISUAL INSPECTION, LEAK TESTING, AND CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. ANALYSIS OF THE DEVICE WAS UNABLE TO CONFIRM THE REPORTED PARTICULATE MATTER. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOME CHOICE (HC) MACHINE, THE HOME PATIENT (HP) NOTICED SOMETHING BLACK IN THE PATIENT LINE DURING FILL 1 OF 8, PATIENT CONNECTED. DURING THE FOLLOW UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), IT WAS REPORTED THAT THERE WAS NOTHING BLACK IN THE PATIENT LINE AND THAT THE TUBING WAS POSITIONED ON SOMETHING THAT MADE IT LOOK BLACK. HOWEVER, FURTHER CLARIFICATION WITH THE HP REVEALED THAT THE HP DID SEE SOMETHING VERY SMALL AND BLACK IN THE LINE. THE HP STATED THAT WHEN THEY SQUEEZED THE LINE, THEY SAW IT MOVE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262324 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H13B23086

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE